Clinical Metadata

Web-based metadata management with a CDISC mindset

About

Clinical Metadata is a web-based metadata management solution that helps the pharmaceutical industry achieve CDISC compliance and accelerates the study reporting process.

The software manages clinical trial metadata end-to-end including Raw/ CDASH metadata, SDTM, ADaM and TFL metadata. It assists the standards governance process by managing metadata at the analysis, study, project and global level, allowing metadata fragments to be re-used, promoted, analysed and compared.

Built using the latest tools and techniques, and with a focus on security, transparency and traceability, Clinical Metadata is intuitive to use and promotes collaborative working.

The software's inbuilt analytics and project management functionality offers automated, real-time reporting of study metrics.


Features

Using the latest technologies to simplify clinical metadata management

End-to-end CDISC metadata management

  • Annotated CRF/ Raw/ CDASH metadata
  • SDTM metadata
  • ADaM metadata
  • Titles/ Footnotes and Analysis Results Metadata

Metadata-driven code generation

  • Generate SAS code directly from the metadata
  • Automate repetitive programming
  • Accelerate the development process
  • Improves accuracy

Inbuilt project management tools

  • Track study reporting progress
  • Real-time assessment of study status
  • Automatic reporting on key metrics
  • Easily understand status of metadata artefacts

Metadata visualisations

  • Utilises the latest technologies
  • Visualisation of metadata relationships
  • Understand the impact of metadata changes
  • Graphical standards management

Submission deliverables

  • Automatically create submission deliverables
  • Define.xml
  • Annotated CRF
  • Components of the Reviewer's Guide

User-focused

  • Built around the principles of traceability and transparency
  • Steers users towards CDISC compliance
  • Easy to learn and intuitive to use
  • Created with a focus on security

Contact

Get in touch to find out more or arange a demo